101 / eligibility status check october 21, 2015. i am not your lawyer these materials are public...
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101 / ELIGIBILITY STATUS CHECK
October 21, 2015
I Am Not Your Lawyer• These materials are public information and have been prepared solely for
educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law and practice. These materials reflect only the personal views of the speaker and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, Drinker Biddle & Reath LLP, and the speaker cannot be bound either philosophically or a representative of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the speaker and members of the firm or anyone else. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
• And, nothing represents the views of any sentient life form on the earth or universe, or any parallel universe, alive or dead, fictitious or real! This is for entertainment purposes only and will change rapidly given our understanding of chaos theory.
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35 U.S.C. 101
Status (INSANITY) Check 3 | Overview of Legislative Developments in the US
Where do we stand….
• Statistics– In litigation– Before the PTAB– In prosecution
• Where are we going?– Legislative change?– Sequenom and Supreme Court
help– Versata?
Down Alice’s rabbit hole
4 | Overview of Legislative Developments in the US
Litigation – Eligibility Art Dependent56% survive 101 challenges, but it is art dependent. http://www.mondaq.com/unitedstates/x/297550/Patent/A+View+From+the+Trenches+Section+101+Patent+Eligibility+Challenges+in+the+PostBilski+Trial+Courts
5 | Overview of Legislative Developments in the US
PTAB & The Courts
• Invalidations up since July 2014, PTAB continues the 100% CBM kill rate
http://www.bilskiblog.com/blog/alicestorm/
Total Total Invalid
% Invalid Change since 7/14
Fed Ct. Dec. 141 104 73.8% 1.26%
Patents 346 212 61.3% 0.57%
Claims 6,519 4,672 71.7% -2.99%
Motions on Pleading 67 47 70.1% 1.73%
PTAB CBM Institution 87 75 86.2% 0.31%
PTAB CBM Final 28 28 100.0% 0.00%
6 | Overview of Legislative Developments in the US
Venue Specific Wins?• Venue specific – ED Tex likes patents!• 73.7% invalidity rate
7 | Overview of Legislative Developments in the US
A List of 101 Software “Wins”Delaware & Texas WIN
• DDR Holdings LLC v. Hotels.com, L.P., CAFC• ContentGuard Holdings Inc. v. Amazon.com Inc. (ED Tex. 8/6/15)• The Chamberlain Group LLC v. Linear LLC (ND Ill. 7/7/15)• Freeny v. Murphy Oil Corp., (ED Tex, 5/22/15)• Intellectual Ventures I LLC v. Capital One Financial Corp. (D. Md. 5/12/15)• Kenexa BrassRing, Inc. v. HireAbility.com LLC (D. Mass 4/28/15)• Intellectual Ventures I LLC v. Symantec Corporation (D. Del. 4/22/15)• Messaging Gateway Solutions v. Amdocs (D. Del 4/15/15)• Modern Telecom Systems LLC v. Juno Online Services, Inc. (CACD 3/17/15)• Meritox Ltd. v. Millennium Health, LLC (D. Wis. 2/29/15)• Intellectual Ventures I LLC v. Motorola Mobility, LLC (D. Del. 2/24/15)• TQP Development, LLC v. Intuit, Inc., (E.D. Tex. 2/9/15)• Wavetronix LLC v. Iteris Inc. (W.D. Tex. 2/22/15)• Google, Inc. v. Simpleair, Inc. (PTAB 1/22/15)• Smartflash LLC v. Apple Inc. (E.D. Tex 1/21/15)• Fairfield Industries, Inc. v. Wireless Seismic, Inc. (S.D. Tex. 12/23/14)• The California Institute of Technology v. Hughes Communications (CD Ca 3/3/14)• Card Verification Solutions LLC v. Citigroup Inc (ND Ill 9/29/14)• AutoForm Engineering GmbH v. Engineering Technology Associates, (E.D. Mich 9/5/14)• Helios Software LLC v. Spectorsoft Corp. (D. Del. 9/25/14)
http://ipspotlight.com/2014/11/25/patent-eligibility-after-alice-a-summary-of-decisions-that-found-software-inventions-eligible-for-patenting/
8 | Overview of Legislative Developments in the US
List of PTAB Software 101 “Wins”
• Ex parte Urban, PTAB Appeal No. 2012-005678, 4/3/15
• Ex parte Poisson, PTAB Appeal No. 2012-011084, 2/26/15
• PNC Bank N.A. v. Secure Axcess, PTAB, CBM2014-0010, 9/9/14
• US Bancorp. V. Solutran, Inc., PTAB, CBM2014-00076, 7/7/14– http://ipspotlight.com/2014/11/25/patent-eligibility-after-alice-a-summary-of-deci
sions-that-found-software-inventions-eligible-for-patenting/
9 | Overview of Legislative Developments in the US
3600 – 101 Rejections Post Alice• Statistics are Art Group and Unit Dependent
– See http://www.kilpatricktownsend.com/~/media/Files/articles/2014/Post-Alice%20Exam%20Stats%20In%20Software%20Art%20Units%20A%20Bleajer%20Road.ashx
– http://www.ipwatchdog.com/2014/12/16/post-alice-allowances-rare-in-business-method/id=52675/
10 | Overview of Legislative Developments in the US
3620s, 3680s, 3690s
• 3622, 3623, 3625, 3626, 3627, 3628 & 3629 USPTO description: – “DATA PROCESSING: FINANCIAL, BUSINESS
PRACTICE, MANAGEMENT, OR COST/PRICE DETERMINATION”
– See http://www.uspto.gov/patents-application-process/classes-arranged-art-unit-art-units-2914-3715
– Also true for 3685, 3689, and 3693
11 | Overview of Legislative Developments in the US
Group 1600• Still depends on the art unit
– See related article: http://www.ipwatchdog.com/2015/07/12/trends-in-subject-matter-eligibility-for-biotechnology-inventions/id=59738/
– See for art unit and class description: http://www.uspto.gov/patents-application-process/classes-arranged-art-unit-art-units-1611-17631610 – bio-affecting drugs
1620 – organic compounds1630 – Data processing, chemistry, drug1640 – Drug, bio-affecting1660 – Plants, molecular biology, microbiology1670 – organic compounds
12 | Overview of Legislative Developments in the US
Isolated & Purified
• Ruled insufficient in Myriad to distinguish genomic DNA
• What about other compounds?:– Antibiotics, venoms and toxins, Taxol (yew tree),
chitan / chitosans, enzymes (phytases, cellulases, etc.), fatty acids and fish oils, Taq DNA polymerase (PCR enzyme)
13 | Overview of Legislative Developments in the US
• All new drugs by source / Year 1940s – 2010B = biologicalN = Natural ProductNB = Natural product BotanicalND = Derived from a natural product using synthetic modificationS = syntheticS* = natural pharmacore made by total synthesisV = vaccine
David Newman, J. Nat. Prod. 75(3): 311-335
14 | Overview of Legislative Developments in the US
Endangered?
• Natural antibiotics: carumonam, daptomycin, fosfomycin trometamol, isepamicin, micronomicin sulfate, miokamycin, mupirocin, netilimicin sulfate, RV-11, teicoplanin
• Naturally derived antibiotics - apalcillin sodium, arbekacin, aspoxicillin, astromycin sulfate, azithromycin (Z-pak), aztreonam, biapenem, cefbuperazone sodium, sefcapene pivoxil, cefdinir, cefditoren pivoxil, cefepime, cefetamet pivoxil HCl, cefixime, cefmenoxime HCl, cefminox sodium, cefodizime sodium, cefonicid sodium, cefoperazone sodium…..
15 | Overview of Legislative Developments in the US
Drugs – How Impacted?
• All antiinfectives by class of agent (antibacterial etc.) and how derived
16 | Overview of Legislative Developments in the US
Ariosa Diagnostics Inc. v. Sequenom, Inc. (CAFC 6/12/15)Reyna, Linn & Wallach
• J. Linn: – But for the sweeping language in the Supreme
Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.
17 | Overview of Legislative Developments in the US
Ariosa & Diagnostics
• Average cost to develop and commercialize a diagnostic technology is $50-75 Million
• If we applied Mayo to Claim 1 of the Morse patent would be arguably unpatentable along with Alexander Graham Bell’s patent on the telephone
• YET the Supreme Court did not overrule its decisions of O’Reilly v. Morse (1853) or Dolbear v. American Bell Telephone (1888)– See Adam Mossof & Kevin Noonan Amicus Brief for Ariosa
en banc rehearing.– Where do we go from here?
18 | Overview of Legislative Developments in the US
Ariosa claims
Claim 1• A method for detecting a
paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
• amplifying a paternally inherited nucleic acid from the serum or plasma sample and
• detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
Claim 24• A method for detecting a paternally
inherited nucleic acid on a maternal blood sample, which method comprises:
• removing all or substantially all nucleated and anucleated cell populations from the blood sample,
• amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally [sic] inherited fetal nucleic acid.
19 | Overview of Legislative Developments in the US
WHERE ARE WE GOING??????
20 | Overview of Legislative Developments in the US
Observations
• Filing rates for Group 3600 are decreasing – loss in USPTO fee revenue
• RCE rates down 6% with largest drop in 3600
• USPTO indicates 1.8% decrease in patent filings even though they predicted 5% growth
– http://www.uspto.gov/sites/default/files/documents/20150820_PPAC_Patent_Operations_Update.pdf21 | Overview of Legislative Developments in the US
Statistical Observations• There has been a 25% increase in the average
number of office actions needed to obtain allowance based on these Supreme Court Decisions in Group 1600
22 | Overview of Legislative Developments in the US
Anecdotal Observations• 1600 appeals based on 101 are just now headed to
the PTAB based on public comments from one SPE• Office Actions are increasing delay / cost based on
101 in group specific fashion
23 | Overview of Legislative Developments in the US
What to Watch For• Versata going to the Supreme Court
– 250 PTAB judges v. CAFC – may impact on saving patent appeals• Sequenom possibly going en banc at the CAFC and regardless to the Supreme
Court– En banc review in a potentially patent unfriendly CAFC
• 101 allegations in PGRs coming – Look at CBMs• “Isolated” & “Purified” – where are we?
– Will a synthetic version of a venom, antibiotic, compound extracted from a plant / organism be enough?
• Statutory change to 35 USC 101?• 101 as a defense in malpractice cases• More Comments on Guidance
– Abstract Idea Examples – 1/27/15– Posts July 30, 2015 (examples) and September 3, 2015 (PTAB decisions) http://
www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0
24 | Overview of Legislative Developments in the US
25THANK YOU!!!!
Mercedes K. Meyer, Ph.D., J.D.Washington, DC
@MercedesMeyerLinkedIn: https://www.linkedin.com/in/mercedesmeyer
Bio: www.drinkerbiddle.com/people/attorneys/meyer-mercedes-kPTAB Blog: http://ptabtrialblog.com/
Materials• Kate Gaudry, “Post-Alice, Allowances are a Rare Sighting in Business-Method Art Units, IP
WatchDog Dec. 16, 2014• Gaudry, Grab, McKeon “Trends in Subject Matter Eligibility for Biotechnology Inventions” IP
WatchDog Jul. 12, 2015• Leslie T. Grab & Tina McKeon presentation at Customer Partnership meeting on Trends in
Subject Matter Eiligibility for biotechnology Inventions, Sept. 14, 2015• Hayden W. Gregory, “Patent Eligibility: Should Congress Overrule the Supreme Court’s
Recent Decisions? Would the Court Overrule the Overrule?” July /August 2015 Landside 1.• Amicus Brief of Adam Mossoff and Kevin E. Noonan for 23 Law Professors in Ariosa
Diagnostics, Inc. v. Sequenom, Inc.• “Patent-eligibility after Alice: a summary of decisions that found software inventions eligible
for patenting” see http://ipspotlight.com/2014/11/25/patent-eligibility-after-alice-a-summary-of-decisions-that-found-software-inventions-eligible-for-patenting/
• Robert R. Sachs, #AliceStorm: The Summertime Blues Continue, Bilski Blog, Aug. 29, 2015• USPTO Guidance Information - http://
www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0
26 | Overview of Legislative Developments in the US